Cancer is the leading cause of death worldwide. In many cases, we are finding cancer too late, when it’s already spread, and effective treatment options are more limited. This is why GRAIL is urgently advancing the science and adoption of multi-cancer early detection (MCED).
I’ve written before about MCED’s tremendous promise for unmet clinical and public health needs. Today’s focus is on MCED’s tremendous promise for addressing late-stage cancer treatment costs.
Researchers have consistently found that treatment costs increase by stage across all cancers. For example, treating metastatic cancers can be up to 7 times higher than treating early-stage cancers. Other studies have shown that a cancer diagnosis is associated with significant indirect costs, including reduced productivity, increases in absenteeism, and changes in employment status for both patients and caregivers. For example, unsurprisingly, a recent study showed productivity loss and indirect costs were significantly greater among patients diagnosed with cancer at late versus early stages.
Impact on individuals adds up quickly to an immense system-wide burden. Within the next 10 years, cancer costs are expected to be more than $245 billion annually, with the highest costs among those with late-stage diagnoses.
Just like there is a great financial burden with late-stage and unscreened cancers, there is a great opportunity for doing better. A recent analysis demonstrated that early cancer diagnosis across 19 cancers could result in an estimated $26 billion cost-savings, representing about 17% of the direct costs related to treatment. Additionally, incorporating MCED tests to standard of care screening (SoC) is a highly cost-effective approach compared to SoC screening alone, where adding MCED was found to reduce cancer treatment costs by over $5,000 per patient and improve long-term health outcomes.
To make additional progress in bending the cancer mortality and cost curves, we need to add to our existing screening capabilities. Today, there are screenings available for only three types of cancer for women and two for men, with an additional screening available only for heavy smokers. We must move beyond this limited screening paradigm and shift to screening individuals for many cancers to find cancer when outcomes are better, quality of life is improved, and costs are lower.
So while epidemiologists and economists have been uncovering painful realities about cancer’s financial toll, engineers and biologists are developing technology that finds genetic signals (needles in a haystack) exponentially less expensive and more effectively than ever before. This underlying sequencing technology powers our ability to identify and interpret a common signal for cancer that is being shed into the bloodstream.
GRAIL is committed to translating advancements in genomics into practical applications to dramatically expand earlier detection of cancer. For example, published modeling estimates that adding MCED tests to the existing single cancer screenings could reduce late-stage diagnosis among people aged 50-79 by more than half, with the potential to prevent more than a quarter of cancer deaths expected.
With the societal and individual financial burden of late-stage cancer so high, and the value proposition for MCED so significant, lowering cost must be a focus.
Today, it is possible to sequence a whole human genome for as little as $200 compared to $1,000,000 in 2007. As technological efficiency continues to advance and MCED expands at scale on a population level, we are successfully working towards driving the cost of testing down. Our goal is to make the Galleri test widely available to achieve a fundamental public health impact. The full benefits of early detection can be leveraged to improve outcomes, enhance quality of life, and bend the cost curve on cancer treatment spending. Based on our forecasting, we anticipate that at FDA approval and CMS coverage, and population scale deployment, the cost of the Galleri® multi-cancer test will be $600. We anticipate that price would continue to decrease for Medicare and other large payers as we benefit from our increasing economies of scale.
In the meantime, GRAIL will continue our robust clinical development program established to generate continued evidence of the positive impact MCEDs hold for patients, clinical practice, and the broader healthcare system. This potent combination of scientific breakthrough, trendlines in efficiency, and rigorous data will be vital to unlocking transformative value in cancer care.
Important Galleri Safety Information
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “Cancer Signal Not Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.
If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.
Laboratory/Test Information
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.